FDA grants full approval to Novavax COVID-19 vaccine, but with strict age and health condition limits.
FDA’s Peter Marks resigns, accusing Health Secretary Kennedy of undermining vaccine safety with misinformation.
The FDA has recommended a trivalent flu vaccine for the 2025-26 season, bypassing its independent advisory committee. This decision raises…
The FDA has approved Soliris (eculizumab) for children aged six and older with generalized myasthenia gravis (gMG), offering the first…
Robert F. Kennedy Jr. directs the FDA to end the "self-affirm" rule, requiring companies to disclose and verify food ingredient…
The FDA approves TNKase, a new stroke treatment that dissolves clots faster than alteplase, improving recovery for acute ischemic stroke…
The U.S. Food and Drug Administration has approved Gomekli (mirdametinib) for treating neurofibromatosis type 1-associated plexiform neurofibromas in patients aged…
The FDA has approved Emblaveo, a new treatment for complicated intra-abdominal infections, including those caused by drug-resistant bacteria.
The FDA has approved Journavx, a revolutionary non-opioid drug, providing a safer alternative for acute pain relief without the risk…
The FDA has upgraded the recall for Lay’s Classic Potato Chips to ‘Class I’ after the product was found to…
The FDA has approved Vertex Pharmaceuticals’ Journavx, a new pain medication offering an alternative to opioids with reduced addiction risks.
The U.S. Food and Drug Administration (FDA) has approved monthly maintenance dosing for Leqembi, an Alzheimer's drug developed by Japan's…